RVuptakeLexiDiagnostic and Prognostic Value of the Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI in Patients With Known or Suspected Coronary Artery Disease (CAD).
Colección de datos
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 1 de enero de 2013
Fecha en la que se inscribió al primer participante.Phase 1: Retrospective data collection/analysis All Lexiscan and exercise MPI images on patients performed for clinical indications in calendar year 2010 who had subsequent coronary angiogram within 3 months after index MPI will be retrieved for review by two experts. We will identify different types of RV uptake and RV overload during stress as well as presence or absence of these changes on resting images. Analysis will include increased RV uptake, enlargement, hypertrophy, thinning of RV and flattening of the interventricular septum. Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of the identified pathological RV phenotypes in identifying severe and extensive disease will be evaluated by comparison with contrary angiograms. Comparison of the set of parameters identifying pathological RV changes, identifying normal and abnormal values of these novel ancillary markers, as well as assessing their diagnostic accuracy in patients with suspected and known CAD during vasodilator stress versus exercise stress MPI will be done. Phase 2: Prospective data validation Patients referred for the Lexiscan stress MPI will be followed prospectively after obtaining an informed consent. All comers after June 1 2012 will be included. Prediction of coronary artery disease will be performed by applying the previously derived pathological RV criteria on the prospective stress MPIs. 2D-Echocardiogram will be performed for all the patients who do not have an Echocardiogram performed for clinical indication within 1 month of their index Lexiscan stress MPI. We will also include 100 patients referred for the exercise stress MPI who will serve as controls. All patients will be prospectively followed up for a total of 12 months for the following prognostic end points: Hard cardiac events (cardiac death or MI); Total (all-cause) mortality; Cardiovascular hospitalization rate. Cardiac death (CD) will be defined as death attributable to any cardiac cause (eg, lethal arrhythmia, myocardial infarction [MI], or pump failure) as confirmed by review of death certificate and medical records.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 650 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 89 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: Retrospective population (approximately 300 charts to be reviewed) Patients with MPI and 2D Echocardiogram within one month of the stress testing in calendar year 2010 at University Medical Center, Tucson AZ. 18 years or older. Prospective population (approximately 350 subjects to be recruited) Patients scheduled for MPI at University Medical Center, Tucson AZ. 18 years to 89 years old Exclusion Criteria (applied to both retrospective and prospective arms): patients with nondiagnostic or technically defective MPI incomplete clinical data severe valvular heart disease complex congenital heart disease life expectancy less than one year at the time of the index MPI unable to follow up (absence of permanent address) Known prisoners, pregnant women and cognitively impaired patients.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
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University of Arizona Medical Center
Tucson, United StatesAbrir University of Arizona Medical Center en Google Maps